Knowledge, attitudes and practices of community treatment supporters administering multidrug-resistant tuberculosis injections: A cross-sectional study in rural Eswatini

Background This study assessed knowledge, attitudes and practices (KAP) of lay community treatment supporters (CTSs) delegated with directly observed treatment (DOT) supervision and administration of intramuscular multidrug-resistant tuberculosis (MDR-TB) injections in the Shiselweni region in Eswatini. Methodology A cross-sectional survey among a purposive sample of 82 CTSs providing DOT and administering injections to MDR-TB patients was conducted in May 2017. Observations in the patients’ homes were undertaken to verify CTSs’ self-reported community-based MDR-TB management practices. Results Out of 82 respondents, 78 (95.1%) were female and half (n = 41; 50.0%) had primary education or lower. Over one-tenth (n = 12; 14.6%) had not attended a MDR-TB training workshop, but were administering injections. The overall KAP scores were satisfactory. Good self-reported community-based MDR-TB practices were largely verified through observation. However, substantial proportions of respondents incorrectly defined MDR-TB, were unaware of the treatment regimen, stigmatised patients, and underreported needlestick injuries. There was no statistically significant association between duration administering intramuscular injections, MDR-TB training, knowledge and attitudes, and good community-based MDR-TB management practices. Conclusions The gaps in the current KAP of CTSs in this setting raise questions about the timing, adequacy, design and content of community-based MDR-TB management training. Nonetheless, with appropriate training, lay CTSs in this region can be an option to complement an overstretched professional health workforce in providing DOT and MDR-TB injections at community level.


Introduction
The second component of the training focuses primarily on theoretical themes relating to MDR-TB epidemiology, transmission, diagnosis, treatment/strategies (DOT), safe injection handling, adverse drug reactions, and CTSs' responsibilities including patient confidentiality and procedures for patient referral to community MDR-TB nurses. The training is conducted by members of the formal health services through classroom instruction, group work and open discussions. Although the workshop uses pre-and post-training assessments, no certificates or any formal form of accreditation are given to CTSs on completion of the training. Each CTS receives a monthly stipend and irregular on-going supervisory visits from and at the discretion of the community MDR-TB nurse.
Although task-shifting in TB control is not a new concept in Eswatini, a key tension in the delegation of MDR-TB injection administration responsibilities to CTSs has been the absence of a national policy framework to regulate their recruitment, training and accreditation. Professional bodies have raised ethical concerns about standards of care and safety risks for both patients and CTSs ranging from potential errors in dosing to transmission of infections through unsafe injection handling and inappropriate community MDR-TB IPC practices [8]. As a result, there are fears that task-shifting injection administration to CTSs may create a two-tiered system of MDR-TB management, with "superior" and "inferior" tracks.
Previous extensive systematic literature reviews on task-shifting have established the safety, effectiveness and acceptability of using appropriately trained and supervised lay community health workers (CHWs) in the provision of injectable contraceptives [9] and delivery of vaccines and medicines to mothers and children through compact pre-filled injections [10]. The experience in this case study setting is important given the paucity of programmatic experience globally in the provision of MDR-TB injections by lay CHWs.
This study was conducted to assess the KAP levels of CTSs that may facilitate or impede the supervision of DOT and administration of injection treatment in the community-based MDR-TB programme. Results will help in formulating recommendations for optimising community-based MDR-TB management training for CTSs in the Shiselweni region.

Setting and design
The Shiselweni region, with an estimated population of 204 111 in 2017, has three main health facilities supporting 18 smaller PHC clinics that form part of the regional health network managed by the Ministry of Health [11]. CTSs accompany their MDR-TB patients to the main health facilities for their monthly outpatient treatment review and any unscheduled visits in the case of worsening health condition.
A cross-sectional survey was conducted among CTSs providing DOT and administering injections to MDR-TB patients in the Shiselweni region in May 2017. Direct observation of CTSs supervising DOT and administering intramuscular injections in the MDR-TB patients' homes was conducted and recorded on a structured checklist.

Sampling
A purposive sample of 82 out of a study population of 124 CTSs enrolled in community-based MDR-TB management in the Shiselweni region was considered for the survey. The inclusion criteria were having at least one month experience of and currently administering MDR-TB injections. From a list of the 82 CTSs that participated in the survey, 20 were selected using a stratified sampling method to verify self-reported practices by direct observation. The sampling frame (list of CTSs) for each stratum was obtained from the register of CTSs at each MDR-TB treating facility. Within each stratum, participants were selected through proportionate random sampling to reach a target sample size for each facility-Matsanjeni Health Centre (10), Nhlangano Health Centre (6) and Hlatikhulu Hospital (4). All eligible respondents that were approached agreed to participate in the survey and observations.

Instrument development and measures
An interviewer-administered structured questionnaire consisting of 64 items (S1 File) was developed based on literature review and CTS training materials and job descriptions [12][13][14][15][16]. The content validity of the questionnaire was assessed by expert opinion. The internal reliability of the KAP scale was found to be acceptable and had a satisfactory discriminating power with subscale Cronbach's alpha co-efficient for knowledge, attitude and practice of 0.72, 0.68 and 0.62 respectively [17][18][19][20][21].
The questionnaire collected socio-demographic details as shown in Table 1. There were 25 knowledge-related questions that examined the definition of MDR-TB, its aetiology, transmission, main symptoms, diagnosis, treatment, safe injection handling, and IPC as shown in Table 2. Respondents were asked to choose the correct response on a given statement on a scale that ranged from 1 ("yes"), to 2 ("unsure"), and 3 ("no"). Responses to knowledge questions were assigned a score of 1 for correct and 0 for inappropriate or uncertain responses. CTSs' attitudes towards community-based MDR-TB management were measured using 21 statements. Participants chose either "strongly agree" (5 points), "agree" (4 points), "unsure" (3 points), "disagree" (2 points) and "strongly disagree" (1 point) on a 5-point Likert-type scale as shown in Table 3. CTS's self-reported practices regarding MDR-TB were assessed based on responses to 12 questions as shown in Table 4. The self-reported practices were verified by carrying out observations in a sample of 20 CTSs using a structured observation checklist, as shown in Table 5. The questionnaire was availed in both English and the local language siSwati. The instrument was pretested for practicality among 10 CTSs who were no longer administering MDR-TB injections and were excluded from the study. A structured observation checklist (S2 File) for verifying CTSs' self-reported community-based MDR-TB management practices was developed based on a schedule used by community MDR-TB nurses in supervising CTSs and literature review [22][23][24][25]. The checklist comprised of 26 items recording CTSs' TB IPC, DOT, and injection administration practices.

Participant recruitment and data collection
CTSs accompanying their MDR-TB patients for their monthly review at the three MDR-TB treating facilities were informed about the research (interviews and observations) by the community MDR-TB nurse at the end of their consultation. The CTS was then referred to a trained research assistant stationed in a private room within the MDR-TB unit at the health centre. Three research assistants with previous experience in data collection were recruited for the study. A two-day training workshop provided an overview of the study, basic knowledge of MDR-TB is best treated with the following drug combination: rifampicin, kanamycin and levofloxacin only (no)

(13.4)
The standard length of injection treatment for a newly diagnosed case of MDR-TB is eight months (yes)

(92.7)
Kanamycin is the drug that is used for injection during the intensive phase (yes) 28 (34.2) The duration of treatment for MDR-TB is between 18 and 24 months (yes) 77 (93.9) Sometimes people with MDR-TB do not get better because they do not take their medication (yes) 80 (97.6) Medications with visible contamination or breaches of integrity (e.g. cracks, leaks) should be discarded (yes)

(96.3)
Swabbing before injections will minimise the pain during injection (no) 36 (43.9) Recapping of used needles can cause needlestick injuries (yes) 76 (92.7) Taking antiretroviral drugs as post-exposure prophylaxis (PEP) can reduce the rate of infection in healthcare workers exposed to HIV through needlestick injuries (yes)

(59.7)
An infection or boil on the injection site is a side effect related to the injection that should be reported to the community MDR-TB nurse (yes) MDR-TB and TB IPC, data collection instruments, and the procedure for obtaining voluntary informed consent from respondents. The entire data collection process was pilot-tested with the research assistants during a field practice visit at one MDR-TB treating facility. For the observation visits, the first author accompanied community MDR-TB nurses during their routine supervisory visits to MDR-TB patients' residences and verified CTSs' self-reported MDR-TB practices using the structured observation checklist. Participation in the study was voluntary and not linked to the CTSs' job security. No rewards were offered for participating in the research. No personal identifying information was collected and findings were reported anonymously using aggregate analysis. Verbal and written informed consent was sought from all MDR-TB patients and CTSs prior to their participation in the interviews and observations respectively.

Analysis
Data was captured and cleaned in Epi Info 7 before being exported to Stata Version 14 for analysis (S3 File). Descriptive statistics were used to summarise the data. Total KAP scores on each of the scales were obtained from the composite scores and converted into percentages. Knowledge scores were classified as poor (� 39.9%), moderate (40.0% -69.9%) and good (� 70.0%). Composite attitude scores � 80% were considered as positive. Respondents with practice scale scores < 75% and � 75% were considered to display poor and good community-based MDR-TB management practices respectively. Three relatively similar studies were used to inform cut-off points for good levels of MDR-TB KAP [12,16,26]. Results from direct observation on CTSs' MDR-TB practices were expressed as percentages. Binomial logistic regression analysis was used to establish factors that were significantly associated with good community-based MDR-TB management practices. The level of statistical significance was considered at p value < 0.05 and 95% confidence interval (CI).

Ethical clearance and authorisation
Ethical approval was obtained from the Scientific and Ethics Committee of Eswatini and the University of the Free State's Health Sciences Research Ethics Committee (IRB00006240). Authorisation of the study was granted by the NTCP and MSF.   Table 1 presents a summary of the demographic characteristics of the study sample. A large majority of participants (n = 78; 95.1%) were female and 33 (40.2%) were older than 50 years. Half (n = 41; 50.0%) of the respondents had low literacy and numeracy skills (primary education or lower) compared to the other half with secondary or higher education.

Results
The length of service of respondents administering MDR-TB injections ranged from 1 to 8 months, with a mean duration of 5.8 months. More than one-tenth (n = 12; 14.6%) of newly recruited CTSs administering injections had not yet attended the 3-5 days theoretical training on community-based MDR-TB management.

Assessment of CTSs' MDR-TB knowledge
The mean knowledge score for the respondents was 70.8% (standard deviation [SD]: ± 8.0%) with correct responses ranging from 40.2% to 88.2%. Overall, 71.9% and 28.1% of the CTSs

Safe injection handling technique
Hands washed before procedure 20 100 New single needle and single syringe used 20 100 Vial checked for content, dose, and expiration date 20 100 Syringe filled with contents of the vial 20 100 Air expelled from syringe 20 100 Careful disposal of the drawing up needle from syringe and replacement with a fresh one 20 100 Exact site for injection located 20 100 Injection site disinfected with alcohol preparation pad 20 100 Patient advised to relax the muscle had good or moderate knowledge scores respectively. However, poor knowledge was apparent in responses to some individual questions relating to the definition, transmission, diagnosis and treatment of MDR-TB as well as safe injection handling, as shown in Table 2. Less than two-thirds (n = 48; 58.5%) of the respondents correctly defined MDR-TB. Over four-fifths (n = 71; 86.6%) incorrectly identified the drug combination used in the treatment of MDR-TB. More than half (n = 46; 56.1%) incorrectly answered that swabbing before injections minimises pain during injection. However, a large majority of the CTSs (n = 73; 89.0%) correctly recognised injection site reactions as adverse effects of the intramuscular injection treatment that required timely referral.

Attitudes
The mean attitude score of the CTSs was 93.5% (± 9.9%), ranging from 55.6% to 100% of appropriate responses. Overall, a large majority of respondents (n = 71; 86.6%) reported positive attitudes regarding community-based MDR-TB management. Despite these positive attitudes, just more than a quarter (n = 21; 25.6%) of CTSs did not consider MDR-TB to be a major public health threat in Eswatini, as shown in Table 3. More than half (n = 45; 54.9%) of the respondents believed that taking traditional medicines was not a hindrance to MDR-TB management. Almost nine in every ten (n = 71; 86.6%) respondents expressed fear of acquiring MDR-TB infection. More than one-third (n = 29; 35.4%) of the CTSs incorrectly believed that MDR-TB patients were themselves to blame for their condition.

Practices
The mean practice score of CTSs was 83.9% (± 11.81%), ranging from 46.7% to 100% of good practice responses. Overall, a majority of respondents (n = 62; 75.6%) reported good practices regarding implementation of TB IPC measures, DOT and safe injection handling procedures as shown in Table 4. Some of these self-reported good practices were verified through observations (Table 5).
Self-reported environmental IPC practices were well applied and this was confirmed by the observation that all windows of the patients' rooms were open. A majority (n = 79; 96.3%) of respondents reported wearing a N95 disposable respirator when attending to a MDR-TB patient. However, none of the MDR-TB patients visited was observed wearing a surgical mask due to lack of supplies. Also one-fifth (n = 4; 20.0%) of the CTSs did not perform hand hygiene after patient contact.
The DOT card revealed that all CTSs consistently administered injections and oral medications daily. In the observations carried out, checking for sterility and expiry of syringes and vials; and the correct dosage, site and technique of injection was noted. Nine respondents (11.0%) reported having sustained a needlestick injury during practice. Of these, only two were reported and post-exposure prophylaxis (PEP) was reportedly not recommended. Reasons for not reporting needlestick injuries included that the injury occurred before administering the injection (n = 4); perceived low risk of infection from the injury (n = 1); lack of awareness about the need to take PEP (n = 1); and job security fears (n = 1).

Predictors of good community-based MDR-TB management practice
Socio-demographic factors, i.e. duration administering injections, having attended MDR-TB training, sound MDR-TB knowledge and positive attitudes, were considered as potential explanatory variables for good community-based MDR-TB management practice. A bivariate logistic regression analysis (Table 6) found no significant association between individual socio-demographic variables such age, level of education, duration administering injections, MDR-TB training, knowledge and attitudes and good community-based MDR-TB management practice. A binomial logistic regression analysis revealed that after controlling for other variables in the model, none of the predictor variables were statistically significant.

Discussion
This study contributes to extant knowledge about task-shifting by assessing the KAP of CTSs in community-based MDR-TB management in the Shiselweni region. While the overall level of CTSs' KAP relating to community-based MDR-TB management was satisfactory, the study identified some important gaps that deserve attention, in particular, the timing, adequacy, design and content of the training provided to CTSs.
The overall satisfactory KAP scores in this study masked substantial weaknesses in some aspects of CTSs' community-based MDR-TB management. Regardless of socio-demographic characteristics, some respondents were not aware of the definition of MDR-TB, its transmission, the rationale behind swabbing before administering an intramuscular injection and demonstrated unfamiliarity with drugs and regimens used in the treatment of MDR-TB. Similar results were found among healthcare workers in other countries [15,16,27,28]. Failure to identify medication names and fundamentals behind MDR-TB treatment care plan may adversely affect the ability of CTSs to recognise the doses, schedules and possible drug side effects during their interaction with patients.
Given CTSs' limited formal education and lack of familiarity with special medical terminology and technical concepts, the present study provides impetus for developing appropriately tailored training material on community-based MDR-TB management. The use of lay conceptualisations and illustrations, and where possible, translated into the local language rather than using training packages developed for formal healthcare workers is recommended. The training course should integrate the theoretical and practical components to enhance a deeper understanding of community-based MDR-TB treatment concepts before delegating injection administration tasks to CTSs. Refresher training should be considered to be as important as the initial training.
The study findings highlighted salient erroneous and potentially stigmatising attitudes among CTSs. For instance, a substantial proportion of respondents inappropriately perceived that MDR-TB patients are to blame for their own condition. Similar to findings reported in previous studies among professional healthcare workers, most CTSs in the current study (86.6%) perceived themselves to have a high occupational risk of acquiring MDR-TB infection [26,29]. Studies from Ghana [30,31] and South Africa [32] have suggested that fear of infection is a major cause of TB stigma and can adversely influence patients' behaviours in accessing MDR-TB services [33][34][35]. These stigmatising attitudes should be addressed in the CTS training design to ensure the development of appropriate relationships between CTSs and their patients [36]. These findings also call for further qualitative research to assess the grounding for MDR-TB-associated stigma among CTSs.
The use of cross ventilation by opening windows and doors in this study was higher compared to observations in studies in Ethiopian (89.2%) and South African (69.0%) hospitals [37,38]. Nevertheless, of concern was the finding of low compliance with basic hand hygiene practice (after injection administration) among CTSs-similar to other studies [26,39]. Key strategies in this setting include the reinforcement of educational initiatives with written reminders for CTSs to recognise hand hygiene opportunities as well as the availability and use of low cost alcohol based hand rub to interrupt the cross-contamination chain [26,[39][40][41].
The observations conducted, albeit limited in number, found the overall intramuscular injection practices of CTSs to be generally satisfactory. These findings were comparable to results reported among professional healthcare workers in a large Indian hospital [42] and CHWs administering injectable contraceptives [9,43]. In the current study, CTSs invariably administered injections and oral medications daily thereby optimising MDR-TB patients' adherence to treatment plans. Nevertheless, and similar to results from studies in Kenya [44] and Nigeria [45], of concern was the underreporting of needlestick injuries by CTSs. Needlestick injuries among healthcare workers can be considered as a cardinal indication of unsafe injection handling practices. Future research should identify strategies to reduce needlestick injuries and improve reporting among reporting-averse CTSs.
Without an enabling national policy on task-shifting, the results highlight potential patient safety and liability risks for the lay CHWs who undertake the delegated tasks [8]. With many health facilities stretched thin by the COVID-19 pandemic, task-shifting to appropriately trained, equipped and adequately supervised lay community members will optimise delivery essential TB treatment to communities. Apart from that, lay community members may play a critical role in facilitating, administering and expanding the reach of the COVID-19 vaccine. As such, there is need to develop conducive task-shifting guidelines to regulate the careful selection, appropriate training, accreditation and continuous supervision of CTSs.
In the present study, a majority of CTSs were female, indicating patients' gender preference in selecting their DOT and MDR-TB injection treatment provider. Research elsewhere has demonstrated that TB patients ought to pick the supporter of their inclination as selection of treatment supporter outside the health system does not adversely affect TB treatment outcomes [46]. Nevertheless, future studies could explore strategies that can strengthen gender equity in the recruitment of these frontline HRH and support male involvement in community-based MDR-TB care.
Converse to findings from previous research, there was no statistically significant correlation between individual socio-demographic variables, knowledge and attitudes and good community-based MDR-TB management practice [16,47]. Future research with a sufficiently larger sample is required to better establish the predictors of good community-based MDR-TB management practice.
With this study mostly founded on self-reported practice and compliance, social desirability bias may have occurred. However, this was partially countered by carrying out structured observations of CTS administering MDR-TB injections to complement survey responses. Respondents were also assured of anonymity of the questionnaires, reporting of findings using aggregate analysis and that the outcomes of the study would not affect their job security or incentives in any way. Although verification of self-reported practice was limited to 20 CTSs due to logistical feasibility, the observations provided the researchers with reasonable insights into CTSs' self-reported KAP and what they actually practice in community-based MDR-TB management.

Conclusion
The study results indicate that in this setting there is the need for considerable strengthening of initial and on-going theoretical and in-service training programmes to reinforce awareness, address gaps in current knowledge and dispel misperceptions and potentially stigmatising attitudes regarding community-based MDR-TB management among CTSs. Taken together, these findings raise questions about the timing, adequacy, design and content of community-based MDR-TB management training provided to CTSs.
Although some problems remain, including the absence of a formal regulation framework for task-shifting and the limited literacy and numeracy skills of most CTSs in this study setting, trained lay CHWs can be an option to complement an overstretched health workforce in providing DOT supervision and administration of intramuscular MDR-TB injections at community level.